Subject: FDA
Serpex Medical Announces Second FDA 510(k) Clearance of Its Steerable Endobronchial Instrument Platform - The Compass Steerable Needle
SANTA CLARA, Calif., Sept. 7, 2022 /PRNewswire/ -- Serpex Medical announced today U.S. FDA 510(k) clearance of its Compass Steerable Needles ? steerable biopsy needles that enable precise access to lung nodules in the intrapulmonary region. Serpex Medical seeks to leverage the power of steerable instruments to enable greater precision and access to improve the diagnosis and treatment of lung cancer. The clearance of the Compass Steerable Needles follows the recent clearance of Serpex's Recon Steerable Sheath.
"The Compass steerable needle is a much-needed innovation," says interventional pulmonologist Dr. George Cheng. "It provides exceptional maneuverability that will enable us to more precisely target and access lesions, at a nominal cost. It's also agnostic in design, so it can be paired with any navigation platform. It is just what we needed."
Lung cancer is the world's leading cause of cancer deaths. Many suspicious lesions found in the lung may be small and difficult to access, which can make diagnosing lung cancer challenging. The slim articulating Compass Steerable Needles provide precise three-dimensional positioning for enhanced reach to all 18 segments of the lung and access to small lesions outside of the airways. The device design allows for a controlled approach to target locations and the ability to sample from multiple aspects of the tumor without unwanted tip deflection, addressing challenging aspects of lung biopsy.
"Precision is essential for confidence in diagnosing lung cancer, especially out in the lung periphery," says Sasha Schrode, President and Chief Executive Officer of Serpex Medical. "We are excited to deliver another innovative product that empowers clinicians to more successfully diagnose lung cancer at an earlier stage."
"This is another significant milestone in the team's pursuit of practical, intuitive innovation," says Duke Rohlen, Executive Chairman of Serpex Medical and Chief Executive Officer of Ajax Health & Zeus Health. "Now with two sets of clearances, Serpex is poised to make a significant impact on the standard of care for patients with lung cancer."
Serpex Medical is backed by Ajax Health, Zeus Health, Aperture Venture Partners and Western Technology Investment.
Serpex Medical is based in Santa Clara, California and is developing innovative steerable technology that will enable greater precision while targeting difficult-to-reach lung nodules, especially those outside of the airway.
Ajax Health seeks to identify, support and scale disruptive technologies in the healthcare space. Taking an active operating role, the Ajax team has a proven track record of helping companies of all sizes, stages and structures achieve their value-creation goals. Ajax Health is headquartered in Menlo Park, CA and backed by an investor group led by HealthQuest Capital and Polaris Partners.
Zeus Health is a platform formed by leading global investment firm KKR focused on investing in and operating a portfolio of emerging medical device companies. Zeus Health is a continuation of the long-standing partnership between KKR and Duke Rohlen.
Media contact:
Sasha Schrode
[email protected]
SOURCE Serpex Medical
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